Intubation tubes (e.g., endotracheal, nasotracheal, and tracheostomy tubes; also called lumens) are used during medical procedures during the administration of anesthesia and critical care medicine and are used to provide access to the upper airways for controlled, assisted ventilation or spontaneous unassisted ventilation.
Conventional intubation tubes available in the market have many inherent dangers related to their complicated design and friability. Further, conventional endotracheal tubes have problems with leakage, due to both over pressurization of the trachea and under pressurization of the trachea, which allows fluids to enter the lungs.
There exists a need for a safer, easier and less invasive method to intubate patients in preparation for a surgical procedure. Intubating patients means to provide a way for the patient to ‘breathe’ during surgery and the traditional method is placing an endotracheal tube down a patient's throat and connecting the tube to a respirator or anesthetic machine. It is necessary for the traditional procedure to have an inflatable ball, or cuff, to seal the tube inside the patient's throat. The tubes currently available are basically made to be disposable and because of their complicated design and moving parts and poor construction, they are very friable and have to be replaced constantly due to failure of the inflation system. Failure of the inflation system during anesthesia can and has been fatal to many patients. The traditional method must be performed by a trained professional because if intubation is performed incorrectly there are risks of damaging the lining of the trachea or even causing tracheal rupture which can lead to death of the patient. It is worth noting that for both human use and animal use (i.e., veterinary use), technicians receive specific training and are certified for the traditional intubation procedure.
Another complication caused by conventional intubation tubes is that it is necessary to maintain several different sizes of traditional tubes to avoid damaging the patient's trachea or larynx by selecting the wrong size. This is especially evident in veterinary use where as many as 14 sizes or more are required to intubate the various sizes of dogs, cats and farm animals. Selecting the correct traditional tube size is very important and underscores the need for a trained technician to implement the traditional method of intubation. The number of sizes creates inventory issues and leads to confusion as to the storage of the traditional tubes.
Conventional intubation tubes and technology use inflation cuffs that allow many dangers to the patient. If the cuff fails or leaks during surgery, which they often do, the patient can wake up during surgery because of not receiving the necessary anesthetic or oxygen, and can also aspirate fluids. More dangerously, the cuff can be over inflated quite easily and cause damage and pressure necrosis to the tracheal mucosa or even tracheal tearing or rupture. The current method used to evaluate the pressure in the inflated cuff is a palpation bulb on the outside of the tube which the operator is supposed to feel and judge the pressure in the cuff. This is at best a crude measurement of the true pressure inside the trachea, and studies have shown that, at times in certain studies, over 50% of the time, the cuff is over inflated causing damage to the trachea. This has become such a wide spread issue that there are now commercial devices such as the Olympic Cuff-Safe™ that is a handheld device that more accurately measures the cuff pressure of the cuffs.
U.S. Pat. No. 3,659,611 filed Dec. 15, 1969, titled “Tracheal Tube Seal” by Don R. Miller, which is incorporated herein by reference in its entirety, describes an improvement in tracheostomy and endotracheal tubes for effecting a substantial air seal between the tube and the trachea and further provides on the periphery of the indwelling portion of the device a series of thin resilient, circular flanges, of silicone rubber, wherein the flanges bend for insertion and withdrawal and engage the wall of the trachea to form an air seal therewith.
U.S. Pat. No. 5,429,127 filed Jul. 6, 1993, titled “Thin Wall Endotracheal Tube” by Theodor Kolobow, which is incorporated herein by reference in its entirety, describes an ultra-thin wire reinforced endotracheal tube which includes a novel sealing design adapted to fit in a complementary manner in a subject's larynx and the endotracheal tube includes a laryngeal section which has a cross sectional shape and size that are complementary to a subject's glottis and preferably, the laryngeal section has an oval or egg-shaped cross section and a plurality of thin, pliable sealing “gills” are provided on the surface of the laryngeal section, wherein the gills provide a fluid tight seal which does not harm a subject's larynx and the endotracheal tube is reinforced with a metallic spring material and in a preferred embodiment, the metallic spring material is a shape memory alloy and the use of a shape memory alloy prevents damage to the endotracheal tube caused by distortion, such as kinking, crushing, etc.
U.S. Pat. No. 5,305,740 filed May 6, 1992, titled “Sealing Means For Endotracheal Tubes” by Theodor Kolobow, which is incorporated herein by reference in its entirety, describes a sealing element for a tubular member such as an endotracheal tube which includes a circular collar portion and a pliable flange or gill, wherein one or more of the sealing elements are positioned on a tubular member such as an endotracheal tube and when the tubular member is inserted into a lumen such as a trachea, the pliable flange(s) or gill(s) forms a seal between the outer wall of the tubular member and the inner wall of the lumen and, in the case of endotracheal tubes and the sealing elements replace conventional inflatable cuffs and allow for tubes having diameters less than 5 mm.
U.S. Pat. No. 5,285,777 filed Aug. 8, 1991, titled “Tracheostomy Apparatus” by Wayne E. Beckwith, which is incorporated herein by reference in its entirety, describes a flexible support plate member mounts straps at opposed ends thereof for securement about an individual, with the plate member receiving a tracheal tube through a receiving plate bore in pivotal relationship, with the tracheal tube including an expandable balloon seal positioned adjacent a lower terminal end of the tracheal tube, with a suction conduit arranged for reception of a catheter tube and a modification of the invention includes sealing ribs and adhesive mounted about the balloon to enhance sealing within the individual.
U.S. Pat. No. 3,516,410 filed Jan. 3, 1968, titled “Cerebro-Ventricular Catheter” by Salomon Hakim, which is incorporated herein by reference in its entirety, describes a ventricular catheter for use with ventriculoatrial shunting devices, and consists of a tubing of soft, tissue-compatible material with intake apertures positioned in the wall of the tubing at one end thereof, the end of the tubing preferably being closed and thin membranes of flexible, tissue-compatible material are attached between the holes and extend outward from the wall of the tube wherein the flexibility is such that the lightest contact with attached tissue will bend the membrane and protect the underlying hole and the membrane may be radially slit to facilitate collapsing upon passing of the catheter through tissue and the membranes are long enough, so that when the catheter is inserted in tissue, they cover the apertures to prevent scraping of tissue thereby.
U.S. Pat. No. 5,251,617 filed Dec. 11, 1992, titled “Endotracheal Tube With Concentrically Mounted And Axially Slidable Connector” by Gerald S. Linder, which is incorporated herein by reference in its entirety, describes a flexible, cylindrical endotracheal tube is disclosed employing an axially slidable, hollow, cylindrical connector concentrically mounted upon the outer surface of the endotracheal tube near its proximal end; the proximal tip of the endotracheal tube is provided with an annular flange having an outer diameter larger than the inner diameter of the hollow output section of the slidable connector and smaller than the inner diameter of the hollow input section of the connector; a breathing circuit connector may be attached to the hollow input section of the slidable connector for coupling to the hoses of a conventional anesthesiology machine; the slidable connector is axially positionable over the outer surface of the proximal end portion of the endotracheal tube without loss of the airtight seal; the annular, flanged tip of the endotracheal tube may pass into and through the bore of the breathing circuit connector during positioning of the slidable connector; the axial positioning of the slidable connector may occur before intubation, after intubation, or while the patient is in recovery.
U.S. Pat. No. 4,502,482 filed Aug. 11, 1983, titled “Endotracheal Tube Complex” by Victor C. DeLuccia, et al., which is incorporated herein by reference in its entirety, describes an endotracheal complex for insertion into the trachea of a patient, and wherein the trachea branches through the carina trachea distally into two bronchi, includes a tube which has a distal blunt and atraumatically shaped tip so as to restrain passage of the tip beyond the carina tracheae into the bronchi and to serve as an internal palpator to identify an anatomical reference point, and an inflatable cuff near the tip for preventing any air or air component other than oxygen emanating from the source of oxygen to pass to the bronchi; a removable introducer is disposed in the tube and has a beveled end portion to facilitate insertion of the tube through the larynx into the trachea; after the endotracheal tube is inserted into the trachea of a patient, the beveled end portion is removed by pulling on the introducer tube or stylet; the beveled end portion collapses off the blunt end of the endotracheal tube and can be pulled through the endotracheal tube to be removed and discarded; the remaining blunt end of the endotracheal tube, from which oxygen is fed to the patient, is so designed so that it will slip past the carina trachea into either bronchus of the patient; there is also provided a suction tube which fits into the endotracheal tube and which has a distinct curve at its distal end as it emerges from the blunt end of the endotracheal tube so that it can be easily directed to slide down the left or right bronchus of the patient in order to aspirate fluids from the lung.
U.S. Pat. No. 3,616,799 filed Oct. 6, 2009, titled “Tubes With Sail Cuffs For Tracheal Intubation” by Charles H. Sparks, which is incorporated herein by reference in its entirety, describes a cuff having an open ended flaring skirt which is pressed against the tracheal wall during the positive pressure phase of mechanical ventilation of the patient's lungs, wherein the sealing pressure is applied by the ventilating gas itself whereby the pressure of the cuff against the tracheal wall can never exceed that of the ventilating gas and whereby the cuff is relaxed in each breathing cycle when the ventilating gas is not above atmospheric pressure and a slidable sleeve sheaths the skirt for intubation and unsheaths the skirt after intubation, wherein the cuff is used on endotracheal, nasotracheal and tracheostomy tubes.
U.S. Pat. No. 3,599,642 filed Dec. 29, 1969, titled “Endotracheal Tubes” by Roland L. Tindel, which is incorporated herein by reference in its entirety, describes disposable endotrached tubes, wherein the tubes have an adapter portion integral with a body portion through a juncture, with a lumen of substantial constant diameter extending throughout the body portion and juncture, the lumen opening into the adapter through a region of generally nonturbulent flow and, wherein the juncture portion is corrugated to provide a flexible connection at any desired angle between adapter and body portion.
What is needed is an improved apparatus and method for intubating patients.